Demeclocycline Hydrochloride

Product NDC
42806-143
11-digit product format
428060143
Labeler code
42806
Product ID
42806-143_b84008e7-52db-4b3e-a12e-cb939852ff0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Demeclocycline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA065447
Marketing category
ANDA
Marketing start
2015-02-02
Substance
DEMECLOCYCLINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065447-001DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18
A065447-002DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065447-001AB
A065447-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065447-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORALAB2015-08-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A065447-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORALAB2015-08-18782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065447-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065447-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065447-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065447-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065447-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065447-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065447-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065447-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065447-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065447-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065447-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065447-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065447-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065447-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065447-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065447-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065447-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065447-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065447-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065447-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065447-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065447-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065447-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065447-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065447-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065447-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065447-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065447-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065447-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065447-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065447-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065447-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065447-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065447-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065447-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065447-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065447-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065447-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065447-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065447-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Demeclocycline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEMECLOCYCLINE HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
29O079NTYTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905341Internal RxNorm lookup
905347Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
645af8f4-0843-4afb-9ddc-f587f38adb68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dbb1ae-e36f-978d-e5e0-8711031739bcProduct name220150904

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-143-01Demeclocycline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
42806-143-05Demeclocycline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5008
42806-143-30Demeclocycline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-143-01EA - Each42806-14323781d02-eb4a-4f82-a5ae-7d8af1d51cd012015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEMECLOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT29O079NTYTDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
DEMECLOCYCLINEACTIVE MOIETY5R5W9ICI6ODEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
HYPROMELLOSE 2910 (10000 MPA.S)INACTIVE INGREDIENT0HO1H52958DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-143DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]8Current NDC, Legacy NDC, 3 package rows20231221_645af8f4-0843-4afb-9ddc-f587f38adb68.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Demeclocycline HydrochlorideDEMECLOCYCLINE HYDROCHLORIDEPuraCap Laboratories LLC88e03cb0-25f5-41a5-b77f-58ab8f3be1812025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065447
application number: ANDA065447
Demeclocycline HydrochlorideDEMECLOCYCLINE HYDROCHLORIDEEpic Pharma, LLC645af8f4-0843-4afb-9ddc-f587f38adb682023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065447
application number: ANDA065447
ndc (product): 42806-143

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905341demeclocycline HCl 150 MG Oral TabletPSN645af8f4-0843-4afb-9ddc-f587f38adb688
905347demeclocycline HCl 300 MG Oral TabletPSN645af8f4-0843-4afb-9ddc-f587f38adb688
905341demeclocycline hydrochloride 150 MG Oral TabletSCD645af8f4-0843-4afb-9ddc-f587f38adb688
905347demeclocycline hydrochloride 300 MG Oral TabletSCD645af8f4-0843-4afb-9ddc-f587f38adb688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-143-0142806014301100 TABLET, FILM COATED in 1 BOTTLE (42806-143-01) 2015-02-020000-00-00NoNoCurrent
42806-143-0542806014305500 TABLET, FILM COATED in 1 BOTTLE (42806-143-05) 2015-02-020000-00-00NoNoCurrent
42806-143-304280601433030 TABLET, FILM COATED in 1 BOTTLE (42806-143-30) 2015-02-020000-00-00NoNoCurrent